Subsyndromal generalized anxiety symptoms (subclinical anxiety
Conditions
Interventions
Group 1: Group 1 (Hypnosis + Bergamot (Conditioned Stimulus (CS)-match)): Participants receive a digital self-hypnosis intervention via audio recordings during Phase 1 (weeks 1–6
first session ~22 minutes, subsequent sessions ~11 minutes), performed every other day (˜3–4 times/week). During each session, bergamot essential oil (Citrus bergamia) is inhaled via a personal aroma
T1 = 6 weeks later
T2 = 8 weeks later.
Group 2: Group 2 (Hypnosis + Lavender (CS-match)): Participants receive a digital self-hypnosis intervention via audio recordings during Phase 1 (weeks 1–6
first session ~22 minutes, subsequent sessions ~11 minutes), performed every other day (˜3–4 times/week). During each session, lavender essential oil (Lavandula angustifolia) is inhaled via a personal
first session ~22 minutes, subsequent sessions ~11 minutes), performed every other day (˜3–4 times/week). No essential oil is used. During Phase 2 (weeks 7–8), no intervention sessions are provided.
G
Sponsors
Charité – Universitätsmedizin Berlin, Charité Competence Center for Traditional and Integrative Medicine (CCCTIM)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: - Residence in Germany - Sufficient German language skills (all study materials are provided in German) - Internet access and use of a personal internet-enabled device (smartphone/PC) to complete the online intervention - Written informed consent for study participation and processing of pseudonymized data - Willingness to complete the intervention over 8 weeks (Phase 1: weeks 1–6; Phase 2: weeks 7–8) - Subsyndromal anxiety symptoms: GAD-7 score 1–7 at screening - No indication of severe depressive symptoms or relevant suicidality at screening: PHQ-9 total score < 20 and PHQ-9 item 9 = 1
Exclusion criteria
Exclusion criteria: - Evidence of an acute or clinically relevant mental disorder requiring treatment (e.g., generalized anxiety disorder, major depressive episode, bipolar disorder, psychotic disorder, post-traumatic stress disorder, severe personality disorder) - Self-reported history of a clinician-diagnosed mental disorder in the domains of psychotic disorders, bipolar disorder, post-traumatic stress disorder (PTSD), or severe personality disorders (exclusion regardless of screening scores) - Screening indicators of clinical severity or risk, in particular GAD-7 = 15, or PHQ-9 = 20, or PHQ-9 item 9 = 2 - Current psychotherapy or planned initiation of psychotherapeutic/psychiatric treatment during the study period - Intolerance or aversive reaction to essential oils (lavender or bergamot) - Known anosmia (complete loss of smell) - Participation in another interventional study that could affect study outcomes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in subjective relaxation, assessed by the “Calmness–Restlessness (RU)” subscale of the Multidimensional Mood Questionnaire (MDBF), from baseline (T0) to end of Phase 1 after 6 weeks (T1). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in subjective relaxation (MDBF Calmness–Restlessness subscale) from T0 to T2 (end of Phase 2 after 8 weeks) and from T1 to T2. 2. Anxiety symptoms: change in GAD-7 (T0, T1, T2). 3. Perceived stress: change in PSS-14 (T0, T1, T2). 4. Sleep quality: change in PSQI (T0, T1, T2). 5. Psychological well-being: change in WHO-5 (T0, T1, T2). 6. Trait worry: change in PSWQ-d (T0, T1, T2). 7. Session-based relaxation response: pre–post difference in VAS relaxation (0–100) before and after each session (Phase 1 and Phase 2). 8. Physiological markers (subsample): change in heart rate variability (HRV; ECG) and pulse wave variability (PWV; PPG) from T0 to T1. 9. Qualitative exploratory outcomes: free-text responses on participants’ subjective experience of the intervention (T1) and open-ended follow-up responses at 6 and 12 months. | — |
Countries
Germany
Contacts
Public ContactGeorg Seifert
Charité - Universitätsmedizin Berlin, Charité Competence Center for Traditional and Integrative Medicine (CCCTIM)
Outcome results
None listed